C-Reactive Protein: Differences Among Various Assays
MedSun: Newsletter #2, March 2006

The Food and Drug Administration (FDA) has acknowledged possible confusion in the laboratory community and among clinicians and manufacturers as to the indications for use of different C-reactive protein (CRP) assays. As the agency responsible for approving device labeling (including package insert specifications), FDA requires appropriate evidence to support each clinical purpose assigned to assays. Differences between conventional CRP, high-sensitivity CRP (hsCRP), and cardiac CRP (cCRP) assays must be understood in order to meet the regulatory need to designate a CRP assay specifically for cardiovascular risk indications for use.

Additional Information:

FDA Guidance
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077167.htm


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